Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Solicited symptoms were collected for 3730 and 3740 subjects instead of the 3727 and 3739 subjects who were randomized in the study in the Cervarix and the Havrix groups, respectively. These 4 sujects received both vaccines and were included in the denominator of both arm based on the actual vaccine type administered.

Reporting Groups

Description

Cervarix Group

Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Havrix Group

Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Cervarix Group

Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Havrix Group

Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.

Measure Description

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).

Time Frame

Within 60 minutes after vaccination

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.

Reporting Groups

Description

Cervarix Group

Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Havrix Group

Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values

Cervarix Group

Havrix Group

Participants Analyzed [Units: Participants]

3730

3740

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. [Units: Subjects]

Any pain

1627

1610

Grade 3 pain

25

20

Any redness

544

501

Grade 3 redness > 50 mm

0

2

Any swelling

207

201

Grade 3 swelling > 50 mm

0

1

No statistical analysis provided for Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.

10. Secondary:

Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. [ Time Frame: Within 60 minutes after vaccination ]

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.

Reporting Groups

Description

Cervarix Group

Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Havrix Group

Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values

Cervarix Group

Havrix Group

Participants Analyzed [Units: Participants]

380

376

Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants. [Units: Subjects]

Any pain

214

189

Grade 3 pain

2

0

Any myalgia

250

211

Grade 3 myalgia

1

0

Any arthralgia

44

32

Grade 3 arthralgia

0

0

Any gastrointestinal

157

119

Grade 3 gastrointestinal

0

1

Any headache

247

242

Grade 3 headache

1

2

Any rash

31

26

Grade 3 rash

0

0

Any urticaria

3

1

Grade 3 urticaria

0

0

Fever (oral) >= 37.5°C

43

37

Fever (oral) > 39.0°C

0

0

No statistical analysis provided for Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.

13. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (From Month 0 up to Month 48). ]

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

The following analysis "occurence of histopathologically confirmed CIN2+ cases associated with HPV16 or HPV18 infection was not performed, in accordance with the Statistical Analysis Plan submitted to the FDA.